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| Plain Hydrocodone- Good Idea?: Rants and Musings of a Retail Pharmacist |
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by The Redheaded Pharmacist - January 10, 2012
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Provided by The Redheaded Pharmacist
We all know that the narcotic prescription drug abuse problem has become an epidemic. But should that discourage or prevent other pain medications from being developed or approved for sale? Do we even need any more narcotics hitting the market?
Those questions started coming to me as I read this article from The Huffington Post. The article, originally from the Associated Press, talks about a company named Zogenix who is currently testing a new long acting narcotic pain reliever called Zohydro. And what is Zohydro exactly? Well, it’s simply a long acting form of the pain reliever hydrocodone without the acetaminophen or ibuprofen that is added in already available pain relievers like Vicodin or Vicoprofen.
Think of Zohydro as the hydrocodone equivalent of the long-acting oxycodone formulation OxyContin. Currently unavailable as a single entity product, hydrocodone is commonly combined with other pain relievers. If Zohydro comes to market, it would be the first time that hydrocodone would be available as a single product in the U.S.
My question to everyone today is do we need another narcotic pain reliever? Is it a good idea to make a long acting hydrocodone product like Zohydro? Should the Food and Drug Administration (FDA) consider the addiction potential and other factors before approving such a product? Should it be approved at all?
According to the AP story, Zohydro is in clinical trials now and could hit the market in the United States as early as the beginning of 2013. The product would be a controlled release, twice daily dosing form of hydrocodone. It’s developer, Zogenix, states that the drug has promise and that it would be another viable treatment option for chronic pain sufferers. But concerns that the drug will be abused like OxyContin have caused some to worry about the validity of the FDA approving this medication.
When I first heard about the proposed hydrocodone product, I wondered why it wasn’t developed as a single entity product from the start. Then I realized that any single hydrocodone product would have to be a Schedule II Controlled Substance. And while that C-II status does indicate that a medication has higher addiction potential, the extra restrictions on those kinds of medications hardly prevents abuse, addiction, and diversion from happening. Drug manufacturers usually try to avoid the C-II status if possible. So back when Vicodin was developed, acetaminophen was added to the formulation and the drug was classified down a ring on the controlled substance scale in the U.S.
Any long-acting hydrocodone product does run the risk of becoming “OxyContin’s little brother” on the street. The potential for abuse here scares me. If developed, Zohydro could become the next major abused drug of choice. You can almost picture the 20/20 headlines on this drug already. It’s almost inevitable that this new drug becomes just another highly abused medication unless it’s approved with severe sales restrictions. But even then, people seem to find a way to get and abuse anything that is legally sold in the U.S.
So what’s the answer to the question of whether this medication should be approved or not? Do we need this as an alternative therapy for those chronic pain patients that can’t take other medications like OxyContin? Would this be a unique therapy worthy of approval or is this just a stronger and more addictive form of the already commonly abused drug Vicodin?
I do like the idea of having another treatment option available for chronic pain patients. Patients should have every available option for treatment possible at their disposal. I wouldn’t want to deny anyone a treatment that could potentially make their individual pain managable. Most practitioners I think would agree that more treatment options are better than fewer choices for their chronic pain patients.
But concerns for helping chronic pain patients or giving practitioners another option for treatment is not what worries me. Many people think that a drug like plain hydrocodone doesn’t add anything significant clinically to a treatment model, but still opens the door for more drug abuse and addiction. The last thing we need is to fuel the addiction fire already fully burning all across the country.
So where does that leave regulators that must make the final decision to approve or reject a drug like Zohydro? Perhaps a significantly restricted use requirement would be a good compromise? That would allow for the development and approval of Zohydro, while still maintaining as many safeguards against drug abuse and addiction as possible. Would that be a reasonable compromise or would sales restrictions even work to prevent the inevitable addiction problem from happening after this drug is approved?
I’m not sure what to think about the idea of developing Zohydro. My gut tells me though that this is a really bad idea and that it will just create yet another highly abused drug for addicts without really adding anything substantial to the treatment options for legitimate pain patients. And to me that sounds like a bad idea that should be reconsidered.
What do you think? Is a stand alone hydrocodone product like Zohydro a good idea or should the FDA prevent such a drug from ever coming to market out of safety or abuse concerns? Do we really need another OxyContin approved for sale in the U.S. with all of the negatives associated with it? Is that even a fair analogy? What do you think?
The Redheaded Pharmacist
The Redheaded Pharmacist has been working full time in retail pharmacy for more than a decade. He is in his mid 30s, and, yes, he has red hair.
Disclaimer: This blog represents the opinions of the author and the author alone. It does not represent any pharmacy group or organization. I also will leave out or change the names of patients/customers to protect their privacy and comply with government regulations regarding patient privacy rights and personal information.
The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.
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| Marty (Florida) |
on 13 Jan 2012 at 11:34 am |
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| As a pharmacist in recovery and someone who has worked in the addiction treatment arena, it is a bad idea. You are correct in your belief that it would only worsen the problems of opiate addiction in this country. Kids don't need another drug with big-time abuse potential. By the way, the new product wouldn't be C-II unless it contained more than 15 mg per unit dose. |
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| Dr.Steve (Colorado) |
on 10 Jan 2012 at 7:07 pm |
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| I agree with most of what you said, however, we need an alternative to oxycodone and morphine which are acetaminophen free. I feel that plain hydrocodone is a great alternative for patients that can not take acetaminophen It's less addicting and not as powerful a kick as the other 2 choices. I have lots of patients that can not take acetaminophen. I like the choice. |
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